MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-UC-3013-53

Device Problems Inability to Auto-Fill (1044); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: the fse replaced the main board but observed another problem of autofill failure. During diagnosis the fse found a low vacuum measured in service diagnostic. The autofill failure was still present. After further diagnosis, the fse found that the solenoid pcb was also defective and need to be replaced which will be arranged soon and replaced. The solenoid pcb and safety disk were replaced. The machine is now working fine. The iabp unit was returned to the customer and cleared for clinical use. All functional and safety checks were to meet factory specifications. A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during a routine check conducted by the customer the cs100 intra-aortic balloon pump (iabp) was not powering, continuous alarms, and had an autofill failure. There was no patient involvement, and no adverse event was reported.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12975357
• MDR Text Key: 282044274
• Report Number: 2249723-2021-02819
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0998-UC-3013-53
• Device Catalogue Number: 0998-UC-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse